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An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This study will include a double-blind Dose Titration/Bridging Period of 8-10 weeks in which SPN-817 will be titrated to the participant's maximum tolerated dose based on response. Following the Dose Titration/Bridging Period, participants will enter an Open Label Extension (OLE) Period of 42-44 weeks. When participants finish the OLE Period, they will initiate a Tapering Period (up to 4 weeks) followed by an End-of-Tapering Period video contact (VC) after the last dose of study drug. The duration of study treatment before starting the 4-week Tapering Period will be one year (52 weeks).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Start Date
July 30, 2025
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
October 10, 2025
100
ESTIMATED participants
SPN-817
DRUG
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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